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Last Updated: September 21, 2020

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Protriptyline hydrochloride - Generic Drug Details

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What are the generic drug sources for protriptyline hydrochloride and what is the scope of patent protection?

Protriptyline hydrochloride is the generic ingredient in two branded drugs marketed by Epic Pharma Llc, Hikma, Sigmapharm Labs Llc, Heritage Pharma, and Teva Womens, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for protriptyline hydrochloride. Five suppliers are listed for this compound.

Recent Clinical Trials for protriptyline hydrochloride

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SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4
Roxane LaboratoriesN/A

See all protriptyline hydrochloride clinical trials

Pharmacology for protriptyline hydrochloride
Medical Subject Heading (MeSH) Categories for protriptyline hydrochloride

US Patents and Regulatory Information for protriptyline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sigmapharm Labs Llc PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 090462-002 May 3, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 202220-001 Nov 19, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharma VIVACTIL protriptyline hydrochloride TABLET;ORAL 073644-001 Aug 24, 1995 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 078913-001 Sep 16, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Womens VIVACTIL protriptyline hydrochloride TABLET;ORAL 016012-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharma VIVACTIL protriptyline hydrochloride TABLET;ORAL 073645-001 Aug 24, 1995 AB RX No Yes   Start Trial   Start Trial   Start Trial
Epic Pharma Llc PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 202220-002 Nov 19, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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